check_circleStudy Completed

wet age-related macular degeneration

Bayer Identifier:

20359

ClinicalTrials.gov Identifier:

NCT03939767

EudraCT Number:

Not Available

EU CT Number:

Not Available
Assessment of proactive treatments in patients with wet age-related macular Degeneration (wAMD) which have never undergone treatment of this particular disease

Trial purpose

In this observational study researchers want to learn more about changes in visual acuity (clarity of vision) with proactive flexible treatments over time in patients suffering from wet age-related macular degeneration (wAMD) after decision to treat with Aflibercept (Eylea) was made. Wet AMD is an eye disease that progressively destroys the macula, the central portion of the retina, impairing central vision.

Key Participants Requirements

Sex

All

Age

50 - N/A
  • - A diagnosis of wAMD.
    - Patients for whom the decision to initiate treatment with IVT aflibercept in a proactive regimen was made as routine clinical practice.
    - Treatment-naïve in the study eye (no prior therapy for wAMD).
    - Patient age ≥50 years of age.
    - Written informed patient consent before the start of data collection (according to the requirements of the local authorities and laws).
  • - Participation in an investigational program with interventions outside of routine clinical practice.
    - Patients with contraindications to IVT aflibercept listed in the local marketing authorization.
    - Planned treatment regimen outside of the local marketing authorization.
    - Patients with eye diseases, e.g. advanced glaucoma or visually significant cataracts, likely to require surgery during the observation period in the study eye.
    - Concomitant ocular or systemic administration of drugs up to 3 months before IVT aflibercept treatment that could interfere with or potentiate the mechanism of action of IVT aflibercept, including other anti-VEGF agents in the fellow eye.
    - Any other retinal disease which may interfere with the treatment of wAMD.

Trial summary

Enrollment Goal
1563
Trial Dates
May 2019 - October 2023
Phase
Phase 4
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
Many LocationsMany Locations, Argentina
Active, not recruiting
Many LocationsMany Locations, Australia
Active, not recruiting
Many LocationsMany Locations, Belgium
Active, not recruiting
Many LocationsMany Locations, Canada
Active, not recruiting
Many LocationsMany Locations, China
Active, not recruiting
Many LocationsMany Locations, Denmark
Active, not recruiting
Many LocationsMany Locations, France
Withdrawn
Many LocationsMany Locations, Greece
Active, not recruiting
Many LocationsMany Locations, Ireland
Active, not recruiting
Many LocationsMany Locations, Norway
Active, not recruiting
Many LocationsMany Locations, Republic of Korea
Active, not recruiting
Many LocationsMany Locations, Spain
Active, not recruiting
Many LocationsMany Locations, Sweden
Active, not recruiting
Many LocationsMany Locations, Thailand
Active, not recruiting
Many LocationsMany Locations, United Kingdom
Active, not recruiting
Many LocationsMany Locations, Colombia
Active, not recruiting
Many LocationsMany Locations, Italy
Active, not recruiting
Many LocationsMany Locations, Switzerland

Primary Outcome

  • The change in BCVA (best corrected visual acuity)
    In treatment-naïve wAMD patients treated with IVT aflibercept in a flexible proactive treatment pattern (fixed dosing or T&E (Treat and Extend Regimen)) by label regimen.
    date_rangeTime Frame:
    Baseline to 12 months

Secondary Outcome

  • The change in BCVA
    date_rangeTime Frame:
    Baseline to 24 and 36 months
  • The change in BCVA by intended treatment regimen
    date_rangeTime Frame:
    Baseline to 12, 24 and 36 months
  • The proportion of patients (eyes) gaining or losing a visual acuity compared to baseline
    With letter score of ≥ 0 letters, ≥5 letters, ≥ 10 letters, ≥ 15 letters.
    date_rangeTime Frame:
    Baseline at 12, 24 and 36 months
  • The proportion of patients (eyes) achieving a Snellen equivalent of 20/40 or better (approximately 73 ETDRS letters)
    date_rangeTime Frame:
    At 12, 24 and 36 months
  • The changes in central retinal thickness (CRT)
    date_rangeTime Frame:
    Baseline to 12, 24 and 36 months
  • The number of injections
    date_rangeTime Frame:
    Baseline to 12, 24 and 36 months
  • The distribution of the intervals between injections
    date_rangeTime Frame:
    Up to 36 months

Trial design

Evaluation of an eXtended and proacTive dosing regimEn in treatment-Naïve patients with wet age-related macular Degeneration (wAMD)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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